Optimizing Low Vision Rehabilitation in Emotionally Distressed Patients With Inherited Retinal Diseases

Overview

The purpose of this study is to understand if combining Low Vision Rehabilitation (LVR) with Emotional Regulation Therapy (ERT) can help people with inherited retinal diseases (IRDs) that experience emotional distress related to participants' vision loss. The study team hypothesize that treatment with LVR will produce measurable functional gains and that these effects will be enhanced by ERT-linked improvement among the subgroup of IRD patients with elevated vision-related anxiety.

Interventions

• Behavioral Low Vision Rehabilitation (LVR)
  The initial session will be with an LVR specialist that will recommend vision-enhancing devices and techniques to improve participant's vision and mobility functionality depending on needs. The devices will be given at no cost and include, but are not limited to: magnifiers that participants can hold or wear, glasses attachments that help filter out light to see better, or items that help with glare or seeing color. This session will be followed by at least one session with an occupational thera
• Behavioral Emotion Regulation Therapy (ERT)
  There will be ten 1-hour weekly sessions of specialized psychotherapy with an ERT-trained therapist. These are typically done virtually but may be able to provide in-person sessions to those where this is needed. At the beginning of each session, the therapist will give participant's several questionnaires to learn about participant's experience with ERT. Questionnaires will also be completed after all sessions are completed.

Primary outcome measures

• Determine if LVR improves vision-related disabilities and distress measures by the Michigan Vision-related Anxiety Questionnaire (MVAQ) [Time frame: Baseline to 6 month]
• Determine if LVR improves vision-related disabilities and distress measures by the Michigan Retinal Degeneration Questionnaire (MRDQ) [Time frame: Baseline to 6 month]
• Determine if LVR measures are different between low-distress and high-distress groups accessed at month-6 by MVAQ [Time frame: Baseline, 6 months]
• Determine if LVR measures are different between low-distress and high-distress groups accessed at month-6 by MRDQ [Time frame: Baseline, 6 months]
• Determine if adjunctive ERT treatment in the high-distress arms improves vision-related disabilities and vision-related distress measures greater than LVR alone measured by MVAQ [Time frame: Baseline, 6 months]
• Determine if adjunctive ERT treatment in the high-distress arms improves vision-related disabilities and vision-related distress measures greater than LVR alone measured by the MRDQ [Time frame: Baseline, 6 months]

Secondary outcome measures (8)

• Determine if LVR improves vision-related disabilities and distress measures by the Short Form Survey (SF-36) [Time frame: Baseline to 6 month]
• Determine if adjunctive ERT treatment improves LVR treatment adherence greater than LVR alone measured by the Psychosocial Impact of Assistive Devices Scale (PIADS) [Time frame: 6 months]
• Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Patient Health Questionnaire (PHQ-9) [Time frame: 6 months]
• Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Perceived Stress Scale (PSS) [Time frame: 6 months]
• Determine if adjunctive ERT treatment improves LVR treatment adherence greater than LVR alone measured by the Daughty Device Compliance Questionnaire (DDCQ) [Time frame: 6 months]
• Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Generalized Anxiety Disorder (GAD)-7 [Time frame: 6 months]
• Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Rumination-Reflection Questionnaire (RRQ) [Time frame: 6 months]
• Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Penn State Worry Questionnaire (PSWQ) [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

• Diagnosed with vision impairment with IRD etiology
• Must have had a clinical exam with an IRD specialist within the three months of assignment to Arm
• Have had a Goldmann visual field that was tested with III-4e isopter within the last year
• Have a disability greater than zero theta in any of the domains of Michigan Retinal Dystrophy Questionnaire (MRDQ)
• Have an indication from the IRD specialist that the ocular condition will not deteriorate over the next 1- year
• Able to participate in 10 weeks of ERT sessions while being physically located in Michigan (these will take place in the first 10 months of the study)

Exclusion criteria

• Having other ocular comorbidities including those associated with an IRD such as control of cystoid macular edema (CME)
• Functional needs regarding low vision (i.e. activities of daily living) have been adequately addressed per a study low vision specialist
• Current mental health therapy
• The participant must not have an elevated suicidal intention (SI) or suicide risk based on Patient Health Questionnaire (PHQ-9) further information collected at screening (If suicidal intentions are identified, the study staff will complete the suicide protocol (per protocol)
• If the participant is using medication for mental health or psychiatry concerns, participants must be on a stable dose of the medication (1-month of taking), otherwise will be excluded
• Inability to complete study task requirements

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Michigan — Ann Arbor

Identifiers

NCT: NCT06651736 · HUM00246479 · 1R01EY035016-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗